For the second time in two years, Alexion Pharmaceuticals ALXN +1.00% has run afoul of FDA inspectors, who cited the drug maker for lax manufacturing practices at a plant that makes its only marketed product, the pricey Soliris treatment for combating a rare blood disorder.
The agency cited the drug maker for three production issues found during an inspection this month, and these were separate from problems cited in a March 2013 warning letter that followed an earlier inspection in 2012, according to a filing with the U.S. Securities and Exchange Commission.
The FDA inspection report was not released, but Alexion disclosed that agency inspectors cited a need for “enhanced training around gowning procedures, more frequent environmental monitoring and processes related to identifying the definitive root cause of a prior” sterility failure.
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